BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 3511268 · Received December 10, 2013

    Report

    Report Number
    3004209178-2013-23039
    Event Type
    Malfunction
    Date Received
    December 10, 2013
    Date of Event
    September 6, 2013
    Report Date
    September 6, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A MEDICAL EQUIPMENT COMPANY REPRESENTATIVE WAS INTERROGATING A DEVICE USED EXCLUSIVELY FOR DEMONSTRATION PURPOSES, A POWER ON RESET OCCURRED AFTER INTERROGATION WHEN THE BATTERY VOLTAGE AND IMPEDANCE WERE BEING MEASURED. IT WAS NOTED THE DEVICE WAS IN THE OVO PACING MODE AND THE LOWER RATE WAS VVI-30. THE DEVICE IS NO LONGER BEING USED AS A DEMONSTRATION DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645711 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR06

    Patients

    Seq Age Sex Outcome Treatment
    1